Healthcare Industry News:  Barrett's esophagus 

Devices Gastroenterology

 News Release - May 23, 2006

Nine Clinical Studies Evaluating Safety and Efficacy of HALO360 and HALO90 Systems to Treat Barrett's Esophagus Presented at Digestive Disease Week

LOS ANGELES--(HSMN NewsFeed)--May 23, 2006--BARRX Medical, Inc. today announced that nine clinical studies involving the HALO360 and HALO90 Systems were presented at Digestive Disease Week® (DDW®), May 20-25, 2006, in Los Angeles. The studies demonstrate the benefits of the HALO360 and HALO90 Systems for treating Barrett's esophagus, a precancerous condition caused by chronic acid reflux disease or GERD. Left untreated, Barrett's esophagus can lead to a dangerous form of cancer called esophageal adenocarcinoma--the fastest rising type of cancer in the United States today.

Among data presented, David E. Fleischer, M.D., of Mayo Clinic in Scottsdale, Ariz., shared the results of the study entitled, "Circumferential RF Ablation for Non-Dysplastic Barrett's esophagus (NDBE) using the HALO360 Ablation System (AIM Trial): One-Year Follow-up of 100 patients." The study was conducted in two phases at eight centers to assess dose-response, safety, tolerability and effectiveness of the HALO360 System. The data concludes that the circumferential ablation of non-dysplastic Barrett's esophagus can be preformed without strictures or buried glands. "The initial results are encouraging. It is critical that these patients be followed over years to assess the long term results," said Dr. Fleischer.

Virender K. Sharma, M.D., also of Mayo Clinic in Scottsdale, Ariz., presented data from the one-year results of the "Ablation of Intestinal Metaplasia (AIM-I) LGD Pilot Trial," which is aimed at assessing the safety, tolerability and effectiveness of circumferential ablation using the HALO360 System to treat patients with Barrett's esophagus and low grade dysplasia (LGD). In this study of 10 patients, ablation was delivered twice to the entire length of Barrett's esophagus. Results demonstrated that the circumferential ablation using the HALO360 System safely and effectively eliminated dysplasia in 90 percent of patients and left no strictures or buried glands.

As with the AIM Trial, this trial was extended to a two-year follow-up in order to collect longer-term data and to enable focal ablation of all patients with residual Barrett's with the HALO90 System-- a focal endoscopic ablation device used to treat smaller areas of disease. "Most patients diagnosed with Barrett's esophagus are concerned and afraid this disease will develop into cancer," said Dr. Sharma. "This is an important study that adds another proof point to the efficacy of the HALO360 System and gives these patients another management option."

Kenneth J. Chang, M.D., Professor of Clinical Medicine, University of California, Irvine, Calif., presented data from a study entitled, "Focal Ablation of Barrett's esophagus Using a Novel Endoscopic Device," which assessed the HALO90 System. This study found that when used either to complement the HALO360 System or as a stand-alone treatment, the HALO90 System will significantly improve the cure rates of Barrett's esophagus. "When used either to complement the HALO360 System or as a stand-alone treatment, this pre-clinical data anticipates that the HALO90 System will significantly improve cure rates of Barrett's esophagus," said Dr. Chang.

Barrett's esophagus occurs when GERD causes the cells lining the esophagus to undergo genetic changes that can set the stage for cancer development. Barrett's has traditionally been managed with frequent endoscopic biopsy surveillance to detect progression to cancer. However, many physicians have long recognized the need to more proactively treat Barrett's esophagus, as opposed to watching and waiting for cancer to develop. Ablation, the use of energy to remove the diseased layer of cells from the esophagus, offers treatment for the disease before it has the opportunity to progress to cancer. New healthy tissue replaces the ablated Barrett's tissue in three to four weeks for most patients.

About Digestive Disease Week

Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20-25, 2006 in Los Angeles. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About BARRX Medical, Inc.

BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus, a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD. Its flagship product, the HALO360 System, provides uniform and controlled therapy at a consistent depth, which can remove Barrett's esophagus and allow the regrowth of normal cells. In the largest study conducted, 70 percent of patients were Barrett's-free (at twelve- month follow up). The system used in the clinical trials was cleared by the U.S. Food and Drug Administration in 2001 and has been commercially available since January 2005. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information about BARRX Medical, Inc. and the HALO360 System is available at www.barrx.com.


Source: BARRX Medical

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